What is the recommended starting dose for Caplyta (lumateperone) in adults with schizophrenia?

Recommended Starting Dose of Caplyta (Lumateperone) for Schizophrenia

The recommended starting dose of Caplyta (lumateperone) for adults with schizophrenia is 42 mg once daily, with no dose titration required. 1

Dosing Guidelines

• Caplyta 42 mg is administered as a single daily dose that can be taken with or without food 1
• Unlike many other antipsychotics, Caplyta does not require initial dose titration - patients start and maintain the same therapeutic dose 2
• The medication is available in capsule form with three strengths: 42 mg, 21 mg, and 10.5 mg 1

Special Dosing Considerations

• Hepatic Impairment: For patients with moderate or severe hepatic impairment, the recommended dose is reduced to 21 mg once daily 1
• CYP3A4 Inhibitor Interactions:
  • When used with strong CYP3A4 inhibitors: Reduce dose to 10.5 mg once daily 1
  • When used with moderate CYP3A4 inhibitors: Reduce dose to 21 mg once daily 1
• CYP3A4 Inducers: Concomitant use with CYP3A4 inducers should be avoided 1

Efficacy and Tolerability Profile

• Lumateperone has demonstrated efficacy in two positive well-controlled trials in patients with schizophrenia 3
• The number needed to treat (NNT) versus placebo for ≥30% improvement on PANSS total scores is 8 (95% CI, 5-21) 4
• Most common adverse reactions (incidence >5% and greater than twice placebo) in schizophrenia trials were somnolence/sedation and dry mouth 1
• Discontinuation due to adverse events is uncommon (NNH versus placebo of 389) 4

Pharmacological Properties

• Lumateperone is a first-in-class agent that simultaneously modulates serotonin, dopamine, and glutamate neurotransmission 5
• The unique pharmacology supports benefits across a wide range of symptoms, including social function and depression 3
• In patients switched from other antipsychotics to lumateperone, significant decreases in total cholesterol, LDL cholesterol, body weight, and prolactin have been observed 6

Important Monitoring and Warnings

• As with other antipsychotics, monitor for:
  • Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain) 1
  • Orthostatic hypotension and syncope 1
  • Leukopenia, neutropenia, and agranulocytosis 1
  • Extrapyramidal symptoms and tardive dyskinesia (though rates of akathisia were lower with lumateperone compared to placebo) 4

Clinical Pearls

• Lumateperone has shown a favorable safety profile with low risk of cardiometabolic and extrapyramidal side effects 6
• The medication maintains stable schizophrenia symptoms when patients are switched from other antipsychotics 6
• Unlike many other antipsychotics, lumateperone does not require complex titration schedules, simplifying the initiation of therapy 2